Fact CheckerSign in

NCT06437444Completed

Asthma Crisis in Paediatrics: Impact of a Care Pathway in Primary and Hospital Care

Source: ClinicalTrials.gov · Last updated 1 Oct 2026

Brief summary (registry, in English)

This study aims to evaluate the effect of the implementation of the new Asthma Integrated Care Pathway in the Basque Healthcare Service for the improvement of care for children with asthma attacks and the reduction of variability between professionals and care settings in this care practice. Asthma is the most common chronic disease in children and has a major impact on people's quality of life. The Asthma Integrated Care Pathway is a structured multidisciplinary care plan that details the essential steps in the care of patients with mild-moderate asthma attacks and the coordinated practice of the agents involved as dictated by the evidence. This pathway will include quality indicators of compliance with diagnostic criteria, assessment of severity and prescription of drugs, as well as the experience of families and professionals, which have been collected in meetings designed for this purpose. The study consists in a mixed methods implementation trial with two phases: 1. Phase I: a quantitative evaluation will be carried out to assess implementation outcomes at the professional level through a pretest-posttest quasi-experimental study with paired control group, with a ratio of 1:2. The primary outcome variable will be the overall percentage of bronchodilator treatment with a spacer chamber in children diagnosed with mild-moderate asthma attacks. We will also include as outcomes to be measured the registration rate of the Pulmonary Score, the recording rate of the assessment of persistent asthma symptoms, and the rate of initiation of background treatment in children with persistent asthma symptoms. These variables will be analysed using differences in pre- and post-intervention outcome measures between the intervention and control groups. 2. Phase II: a qualitative evaluation will be carried out through a structured process with discussion groups focused on the identification of the main barriers and facilitators for the provision of recommended clinical practice related to asthmatic crisis in mild-moderate cases established by the Asthma Integrated Care Pathway. A purposive sample of paediatricians stratified by level of care and service organisations will be recruited to ensure that all views are represented in the discussion groups. The structured script will be designed with questions to explore each of the domains of the Theoretical Domains Framework (TDF). The study will be carried out mainly in two integrated healthcare organizations (IHO), which are made up of two primary care areas and the paediatric reference hospital emergency department of both areas, as well as the hospitalisation, intensive care and paediatric pneumology departments of said hospital, to extend in the future the Asthma Integrated Care Pathway to the rest of the Basque Health Service IHOs.

Status (registry)
Completed
Study type
Interventional
Enrollment
249 (actual)
First submitted
26 May 2024
Start date
7 May 2023
Primary completion date
7 May 2026
Lead sponsor
Basque Health Service
Diseases
Asthma
NCT number
NCT06437444

What you commit to

  • Study type: Interventional
  • Participants enrolled: 249
  • From 7 May 2023 to the primary completion date, 7 May 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Criteria the registry did not label

  • Eligibility for professionals:
  • Primary Care paediatricians and nurses
  • Paediatricians and nurses in the Paediatric Emergency Department
  • Paediatricians and nurses on the inpatient ward
  • Paediatric Intensive Care paediatricians and nurses
  • Paediatric Pneumology paediatricians and nurses
    • Eligibility for patients:
    • Patients between 2 and 14 years,that have being attended between the 7 May 2023 and the 7 May 2025, and with an acute episode of asthma, defined as:
  • an episode of wheezing and a previous diagnosis of asthma or with a previous episode of wheezing
  • a first episode in a child older than 2 years with a personal/family history of atopy and/or with an objective response to bronchodilators as assessed by the Pulmonary Score

Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Primary Care Research Unit of Bizkaia
Coordinator of this site? Confirm its status
BarakaldoSpainUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.